Bloopers made by Indian Drug Standards Control organization

Excerpts from the 59th report of the parliamentary standing committee on the functioning of the Central Drugs Standards Control Organization (CDSCO) raise many questions on the functioning and the decisions of the CDSCO

The CDSCO has been criticized by the parliamentary standing committee

The report of the Indian parliamentary standing committee that focuses on the functioning of the Central Drugs Standards Control Organization, is finally out. Read the excerpts and the arguments of the CDSCO below and judge for yourself if the Central Drugs Standards Control Organization is functioning to the best of its abilities.

The report highlighted that the health and lives of patients in India cannot be put to risk in the hope of detecting adverse drug reactions (ADRs) within the country. The CDSCO acknowledged that not a single new adverse drug reaction was reported from anywhere in the country. The evaluation was carried out under a World Bank funded programme (from November 23, 2004-to- June 30, 2008) to detect side effect of drugs.

Many approvals were given to foreign drugs without testing them on Indians. Some of the reasons given for irregular approvals are as follows.

1.The presence of "Serious diseases". We ask - Is the presence of these serious diseases not reason enough to conduct clinical trials in order to ensure that patients in India really benefit from such imported, exorbitantly expensive drugs;

2. The presence of "Rare disease status according to the US FDA". We ask - How can the US FDA decide what the rare diseases are in India?;